NDC 63323-044-41 - Cyanocobalamin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 63323-044
Requested NDC: 63323-044-41
Package NDCs from labels: 63323-044-00, 63323-044-01, 63323-044-41, 63323-044-44
Manufacturer: Fresenius Kabi USA, LLC
Effective date: 2024-12-15
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Cyanocobalamin - Fresenius Kabi USA, LLC	Fresenius Kabi USA, LLC	2024-12-15	HUMAN PRESCRIPTION DRUG LABEL
Cyanocobalamin - Fresenius Kabi USA, LLC	Fresenius Kabi USA, LLC	2024-12-12	HUMAN PRESCRIPTION DRUG LABEL
Physicians EZ Use B-12 Compliance - Asclemed USA, Inc.	Asclemed USA, Inc.	2024-10-05	HUMAN PRESCRIPTION DRUG LABEL
Cyanocobalamin - Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2021-07-08	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-044-00	Physicians EZ Use B-12 Compliance	1 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	1 mL	1000 ug in 1mL	6
63323-044-00	Cyanocobalamin	1 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	1		4
63323-044-01	Cyanocobalamin	25 in 1 TRAY	INJECTION, SOLUTION	25		4
63323-044-41	Cyanocobalamin	1 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	1		3
63323-044-44	Cyanocobalamin	25 in 1 TRAY	INJECTION, SOLUTION	25		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-044	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [ASCLEMED USA, INC.]	6	Current NDC, Legacy NDC	20241008_168f94ea-2faf-4aeb-88a5-8753ad60a1c4.zip
63323-044	CYANOCOBALAMIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20250123_acff4ff3-4435-4995-a117-dbfcdf72334a.zip
63323-044	CYANOCOBALAMIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241220_8b1cdee5-3368-40e4-90bf-31a64df1f38a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-044-00	ML - Milliliter	63323-044	7c5040c2-0354-43d8-8ebb-8a27739fae52	1	2019-10-07
63323-044-01	ML - Milliliter	63323-044	2ed89db3-669d-4f3f-8ce0-e54f60e1cc8a	1	2012-07-24
63323-044-41	ML - Milliliter	63323-044	ab4fa83b-78e6-4dce-82c3-0de939a7301a	1	2019-03-12
63323-044-44	ML - Milliliter	63323-044	eccf56c0-c974-4c3a-adaf-0aafd7f3dceb	1	2019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Cyanocobalamin	ACTIVE INGREDIENT	P6YC3EG204	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
CYANOCOBALAMIN	ACTIVE INGREDIENT	P6YC3EG204	CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
Isopropyl Alcohol	ACTIVE INGREDIENT	ND2M416302	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
Cyanocobalamin	ACTIVE MOIETY	P6YC3EG204	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
CYANOCOBALAMIN	ACTIVE MOIETY	P6YC3EG204	CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
Isopropyl Alcohol	ACTIVE MOIETY	ND2M416302	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING ]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 92 of 92 · 1,824 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	b3b4b176-41f0-4ca8-90d4-3fba5707564a	2014-02-21	Exact identifier unii: 451W47IQ8X
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21	Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13	Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.